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Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.
This Phase 4, prospective, multi-center, open-label study will evaluate safety, platelet count, and subject reported medication satisfaction in adult subjects with chronic ITP after switching to avatrombopag from eltrombopag or romiplostim. At least 100 subjects will be enrolled, 50 (±10) who have received eltrombopag and 50 (±10) who have received romiplostim for at least 90 days prior to study entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avatrombopag | Other | Avatrombopag 20 mg oral tablet formulation for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag Oral Tablet | Drug | Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (Adverse Events) | Safety and Tolerability of Avatrombopag given for 90 days after stopping eltrombopag or romiplostim The incidence and severity of adverse events (AEs), serious adverse events (SAE) and adverse events of special interest (AESIs) will be summarized for all enrolled subjects using counts and percentages. Treatment-emergent AEs and SAEs will be summarized overall, by system organ class, and by preferred term. AESIs will be summarized by event type (thromboembolic events and bleeding events). In addition, treatment-emergent AEs will be summarized by severity and by relationship to study drug. Bleeding events reported during the study will be summarized by WHO grade. | Screening through Day 90 or End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline TSQM Convenience Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Convenience domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sobi Site 110 | Tucson | Arizona | 85745 | United States | ||
| Sobi Site 119 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40101243 | Derived | Tarantino MD, Mosalpuria K, Kolodny S, Zhang J, Vredenburg M, Jamieson BD. Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA. Blood Adv. 2025 Jun 10;9(11):2733-2743. doi: 10.1182/bloodadvances.2024015635. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Avatrombopag | Avatrombopag 20 mg oral tablet formulation for 90 days Avatrombopag Oral Tablet: Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2022 | Dec 4, 2024 |
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|
| Day 90 |
| Change From Baseline TSQM Side Effects Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Side Effects domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. | Day 90 |
| Change From Baseline TSQM Effectiveness Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Effectiveness domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. | Day 90 |
| Change From Baseline TSQM Global Satisfaction Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Global Satisfaction domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. | Day 90 |
| Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | Day 15 |
| Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | Day 30 |
| Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | Day 60 |
| Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | Day 90 |
| Whittier |
| California |
| 90603 |
| United States |
| Sobi Site 123 | Washington D.C. | District of Columbia | 20010 | United States |
| Sobi Site 129 | Miami | Florida | 33143 | United States |
| Sobi Site 120 | Ocala | Florida | 34474 | United States |
| Sobi Site 125 | St. Petersburg | Florida | 33709 | United States |
| Sobi Site 118 | Tampa | Florida | 33606 | United States |
| Sobi Site 126 | Chicago | Illinois | 60612 | United States |
| Sobi Site 109 | Peoria | Illinois | 61614 | United States |
| Sobi Site 124 | New Orleans | Louisiana | 70112 | United States |
| Sobi Site 101 | Bethesda | Maryland | 20817 | United States |
| Sobi Site 103 | Lincoln | Nebraska | 68506 | United States |
| Sobi Site 121 | Chapel Hill | North Carolina | 27514 | United States |
| Sobi Site 116 | Greenville | North Carolina | 27834 | United States |
| Sobi Site 128 | Cleveland | Ohio | 44106 | United States |
| Sobi Site 127 | Philadelphia | Pennsylvania | 19104 | United States |
| Sobi Site 102 | York | Pennsylvania | 17403 | United States |
| Sobi Site 104 | Rock Hill | South Carolina | 29732 | United States |
| Sobi Site 113 | Dallas | Texas | 75246 | United States |
| Sobi Site 108 | Salt Lake City | Utah | 84132 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avatrombopag | Avatrombopag 20 mg oral tablet formulation for 90 days Avatrombopag Oral Tablet: Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability (Adverse Events) | Safety and Tolerability of Avatrombopag given for 90 days after stopping eltrombopag or romiplostim The incidence and severity of adverse events (AEs), serious adverse events (SAE) and adverse events of special interest (AESIs) will be summarized for all enrolled subjects using counts and percentages. Treatment-emergent AEs and SAEs will be summarized overall, by system organ class, and by preferred term. AESIs will be summarized by event type (thromboembolic events and bleeding events). In addition, treatment-emergent AEs will be summarized by severity and by relationship to study drug. Bleeding events reported during the study will be summarized by WHO grade. | All enrolled subjects. | Posted | Count of Participants | Participants | Screening through Day 90 or End of Study |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline TSQM Convenience Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Convenience domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. | All enrolled subjects. | Posted | Mean | 95% Confidence Interval | Mean difference in convenience score | Day 90 |
|
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| Secondary | Change From Baseline TSQM Side Effects Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Side Effects domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. | Posted | Mean | 95% Confidence Interval | Mean difference in side effects score | Day 90 |
|
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| Secondary | Change From Baseline TSQM Effectiveness Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Effectiveness domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. | Posted | Mean | 95% Confidence Interval | Mean difference in effectiveness score | Day 90 |
|
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| Secondary | Change From Baseline TSQM Global Satisfaction Domain Score | Evaluate the change in subject reported outcomes (TSQM - Treatment Satisfaction Questionnaire for Medication) from Baseline. Global Satisfaction domain score ranges from 0 to 100, and a higher score indicates a better outcome. Mean Difference was computed as Day 90 minus Baseline and, therefore, a positive mean difference indicates an increase in the score from Baseline to Day 90. | Posted | Mean | 95% Confidence Interval | Mean difference in global satisfaction | Day 90 |
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| Secondary | Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | All enrolled subjects. | Posted | Count of Participants | Participants | Day 15 |
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| Secondary | Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | Posted | Count of Participants | Participants | Day 30 |
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| Secondary | Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | Posted | Count of Participants | Participants | Day 60 |
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| ||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Have a Platelet Count Between ≥50×10^9/L to ≤200×10^9/L | Posted | Count of Participants | Participants | Day 90 |
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90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avatrombopag | Avatrombopag 20 mg oral tablet formulation for 90 days Avatrombopag Oral Tablet: Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information | 1 | 60 | 6 | 60 | 34 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Sudden Death | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (26.1) | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Peripheral Swelling | General disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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PIs are not allowed to publish clinical trial data on their own after trial completion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medicine Development Leader | Sobi,Inc. | 1-781-786-7370 | medinfo.us@sobi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2024 | Dec 20, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C533238 | avatrombopag |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Related TEAEs |
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| Severe TEAEs |
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| TEAEs leading to study drug discontinuation |
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